FDA Recalls Estradiol Cypionate Vials Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling Estradiol Cypionate 10 mg/mL vials because FDA inspections found GMP violations that may affect sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol Cypionate 10 mg/mL, packaged in 5 mL vials, manufactured by Well Care Compounding Pharmacy in Las Vegas, Nevada. The recall involves 869 units of the prescription-only medication.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The specific lots affected are 03302016:68@10 (exp. 06/28/2016), 03082016:83@38 (exp. 06/06/2016), 02172016:37@51 (exp. 5/17/2016), and 2102016:80@55 (exp. 5/30/2016). The products were distributed in Nevada.
Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on whether to discontinue use and to obtain a replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Injectable Steroid
- Affected units
- 869
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: 03302016:68@10
- Exp.06/28/2016
- Lot #: 03082016:83@38
- Exp. 06/06/2016
- Lot #:02172016:37@51
- Exp. 5/17/2016
- Lot #: 2102016:80@55
- Exp.5/30/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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